Senior Director Regulatory Guidance

21 hours ago


Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time
About the Role:
We are looking for an accomplished Senior Director to join our team as a Regulatory Affairs Leader. You will oversee the Regulatory Affairs team, providing strategic regulatory advice to clients and driving global Regulatory Affairs Strategies.

Responsibilities:
  • Lead client projects, offering expert regulatory guidance.
  • Prepare and review regulatory submission documents.
  • Lead a team of 4 regulatory professionals, supporting development plans and mentoring.


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

    We're seeking a strategic and forward-thinking Director of Regulatory Strategy to join our Regulatory Affairs team at Gilead Sciences, Inc. As a key advisor to our business leaders, you'll develop and execute regulatory strategies that drive business growth and minimize risk.The estimated annual salary for this position is $180,000, based on location and...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job Title: Senior Regulatory Affairs Labeling DirectorGilead Sciences International, Ltd. is seeking a highly experienced Senior Regulatory Affairs Labeling Director to lead the Global Regulatory Labeling team.Key Responsibilities:Develop and implement global labeling strategies to ensure compliance with evolving regulatory requirements.Lead a team of...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    About the Role:Gilead Sciences International, Ltd. is seeking a highly skilled Regulatory Affairs Director, Precision Medicine to join our team.Responsibilities:Develop and Execute Regulatory Strategies: Collaborate with cross-functional stakeholders to develop and execute precision medicine regulatory strategies in alignment with the company's global...


  • Cambridge, Cambridgeshire, United Kingdom Lifelancer Full time

    Regulatory Affairs Director Job OverviewWe are seeking a highly skilled Regulatory Affairs Director to join our team at Lifelancer. As a key member of our organization, you will be responsible for developing and delivering innovative global regulatory strategies for sonelokimab lead indication(s).About the RoleThis is an exciting opportunity to work with a...


  • Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time

    Regulatory Affairs Leadership OpportunityWe are seeking an experienced Senior Director to lead our Regulatory Affairs team at Cpl Life Sciences.Key Responsibilities:Provide strategic regulatory advice to clients, taking into account regulatory guidelines and available measures to facilitate regulatory input.Develop and implement effective regulatory...


  • Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time

    Job OverviewWe are seeking a highly experienced Senior Director to lead our Regulatory Affairs team at Cpl Life Sciences. This role will provide strategic regulatory advice to clients, taking into account regulatory guidelines and available measures to facilitate regulatory input.Key Responsibilities:Lead client projects, providing expert regulatory guidance...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Gilead Sciences International, Ltd. is seeking an experienced Regulatory Affairs Director to oversee regulatory activities in the Gilead Patient Solutions region.About the RoleThis exciting opportunity allows you to leverage your expertise in regulatory affairs to provide strategic guidance and oversight to in-market partners.Key ResponsibilitiesDevelop and...


  • Cambridge, Cambridgeshire, United Kingdom Vertex Ventures HC Full time

    Company Overview:Bicycle Therapeutics is a dynamic pharmaceutical company committed to delivering innovative treatments for challenging diseases. Our team is driven by a passion for innovation and a commitment to excellence.Salary:$220,000 - $270,000 per yearJob Description:We are seeking a seasoned Regulatory Affairs Director with Strategic Expertise to...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    About the Role:Gilead Sciences International, Ltd. seeks an experienced Regulatory Affairs Director to lead our biologics efforts in a dynamic global team environment.Job Summary:This key leadership position requires a seasoned professional with expertise in CMC regulatory affairs and strong leadership presence to oversee EU Regulatory submissions and drive...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    About the RoleWe are seeking an experienced Regulatory Affairs professional to join our global team at Gilead Sciences International, Ltd.Key ResponsibilitiesDevelop and implement regulatory strategies for assigned products or projects.Collaborate with cross-functional teams to shape dossier content for global rollout and life cycle management.Oversee the...


  • Cambridge, Cambridgeshire, United Kingdom Regeneron Pharmaceuticals, Inc Full time

    About Regeneron Pharmaceuticals, Inc.We are a leading biopharmaceutical company dedicated to discovering and developing life-changing medicines for patients worldwide.Job DescriptionSenior Director, Quantitative PharmacologyThis role is responsible for managing PMx support for various programs across different therapeutic focus areas in our development...

  • Senior Tax Director

    3 weeks ago


    Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full time

    Unlock your career potential as a Senior Tax DirectorAre you looking for a role in one of the leading M&A tax teams, delivering on some of the largest buy-outs in Europe and working with the largest private equity houses and infrastructure funds? This opportunity will allow you to expand your M&A skills, gain exposure to a diverse client base, and...


  • Cambridge, Cambridgeshire, United Kingdom Vertex Ventures HC Full time

    Job Title: Compliance and Regulatory Affairs DirectorAbout Bicycle Therapeutics:We are a clinical-stage biopharmaceutical company dedicated to developing innovative medicines for underserved diseases. Our team is passionate about improving the lives of patients and driving meaningful change in the industry.Job Summary:The Compliance and Regulatory Affairs...


  • Cambridge, Cambridgeshire, United Kingdom Lifelancer Full time

    Job DescriptionCompany Overview: Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT.We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains. Our mission is to provide innovative solutions for businesses and professionals in the industry.SalaryThe estimated salary for this position...


  • Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time

    Job Description:In this senior leadership role, you will be responsible for providing strategic regulatory advice to clients across various therapeutic areas. Your expertise will drive global Regulatory Affairs Strategies, and you will play a key part in bringing products through EU approval.Key Requirements:Minimum 12+ years of experience in Regulatory...


  • Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full time

    Job OverviewMoonLake Immunotherapeutics seeks a highly skilled Global Regulatory Affairs Director to lead the development and implementation of innovative global regulatory strategies for sonelokimab lead indication(s).This role will be responsible for regulatory aspects related to product development and approval, aligning with the global business strategy...


  • Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    About the RoleIn this exciting role as Senior Associate, Regulatory Affairs, you will collaborate with internal colleagues and external organizations to support the timely execution of regulatory submissions, responses to questions, audits, and inspections. You will also be responsible for the maintenance of regulatory files and tracking databases, including...


  • Cambridge, Cambridgeshire, United Kingdom Barrington James Full time

    We are seeking a highly skilled and experienced professional to join our board as a Non-Executive Director, with a focus on Quality Assurance. This is an exciting opportunity to make a significant impact on a high-growth company specializing in cutting-edge vaccines and injectables.Your main responsibilities will include:Providing strategic guidance and...


  • Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Key ResponsibilitiesThe successful candidate for the position of Senior Associate, Regulatory Affairs will have a strong understanding of the drug product lifecycle from discovery to clinical trials to marketing. Key responsibilities include:Developing and executing global regulatory strategies for assigned programs or projectsMaintaining working knowledge...


  • Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full time

    Join Hays Senior Finance as an Associate Director of Tax ServicesWe are seeking an experienced tax professional to join our team as an Associate Director of Tax Services. In this role, you will work closely with our clients to deliver expert tax advice and support their business growth. The estimated salary for this role is £100,000 - £130,000 per annum,...